Protocol summary

Summary
This study will be done with aim to investigate the effectiveness of educational intervention based on positive psychology on quality of life and happiness of women with unwanted pregnancies. This is a non-blinded clinical trial. The study population will be included all women with unwanted pregnancies in West Islamabad that 40 eligible pregnant women will be selected and randomly will be assigned into two experimental and control groups. Beginning of the study quality of life and happiness questionnaires will be provided for both groups. Intervention group in addition to usual care of center, will receive training based on positive psychology in 8 educational sessions (if necessary up to 10 sessions) 70-90 Minutes, one session for every week. The control group just will receive the usual care of center. End of the study, and 45 days after the end of the study, quality of life and happiness questionnaires will be provided for both groups and both groups will be compared. Inclusion criteria: Unwanted pregnancy until the twentieth week of gestational age; No history of infertility; Lack of pregnancy complications; Lack of diagnosed physical and mental illness; Independent of the participant or his wife to drug and psychotropic substances; Residence in West Islamabad; No participation in similar training sessions; At least educational level at end of the primary school. Exclusion criteria: More than two sessions lack of participation in training sessions; Withdrew to participate in the study; Abortion or termination of pregnancy during the study

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030714333N70
Registration date: 2017-04-02, 1396/01/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-03-15, 1395/12/25
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness and non-effectiveness of educational intervention based on positive psychology on quality of life and happiness of women with unwanted pregnancies
Public title
The effectiveness of educational intervention based on positive psychology on quality of life and happiness of women with unwanted pregnancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Unwanted pregnancy until the twentieth week of gestational age; No history of infertility; Lack of pregnancy complications; Lack of diagnosed physical and mental illness; Independent of the participant or his wife to drug and psychotropic substances; Residence in West Islamabad; No participation in similar training sessions; At least educational level at end of the primary school. Exclusion criteria: More than two sessions lack of participation in training sessions; Withdrew to participate in the study; Abortion or termination of pregnancy during the study
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, ShahidBeheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
kums.rec.1395.717

Health conditions studied

1

Description of health condition studied
Quality of life
ICD-10 code
z34.8
ICD-10 code description
Supervision of other normal pregnancy

2

Description of health condition studied
Happiness
ICD-10 code
f30-f39
ICD-10 code description
Mood [affective] disorders

Primary outcomes

1

Description
Happiness
Timepoint
The beginning of the study, end of the study and 45 days after the end of the study
Method of measurement
According to the Oxford Happiness Inventory (OHI)

2

Description
Quality of life
Timepoint
The beginning of the study, end of the study and 45 days after the end of the study
Method of measurement
Based on the quality of life questionnaire (SF-36)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group in addition to usual care of center, will receive training based on positive psychology in 8 educational sessions (if necessary up to 10 sessions) 70-90 Minutes, one session for every week.
Category
Other

2

Description
The control group just will receive the usual care of center.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Islamabad Gharb
Full name of responsible person
Zahra Rastad
Street address
Eslamabad Gharb
City
Eslamabad Gharb

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Rastad
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
z.rastad2014@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marzieh Kaboudi
Position
Ph.D. in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 838279394
Fax
Email
fkaboudi@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Rastad
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
z.rastad2014@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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